19th March to 20th March 2018,
London, United Kingdom

£400

SMi is pleased to present the return of their 12th annual Paediatric Clinical Trials Conference taking place on 19th – 20th March 2018, London, UK.

Clinical trials in paediatric populations still pose several challenges and often many studies remain un- published*. 10 years on from the introduction of EU Paediatric Investigation Plans (PIPs) there are still many lessons to be learned about the planning and execution of trials which should be tailored around the needs of children.
Recent advancements in immuno- oncology research has led to an increase in clinical trials to treat cancer in children and adolescents. Greater emphasis has also been placed on pain-free administration of drugs in the bid to increase vaccination uptake and access to medicines.

Join us as we discuss current clinical trials and the innovative digital technology being used to improve clinical recruitment and retention as well as improve the quality of data being collected. leading industry experts will be looking at how to work within regulations and foster the involvement of young people in their care. We will also be looking at the planning and executing a paediatric clinical trial and the ways this can vary according to region. We will be exploring the complexities of paediatric drug formulation and helping you determine clinical endpoints.

• Explore advancements technology for clinical trials and data collection for paediatric drug development
• Review and discuss paediatric clinical trial Legislation in the EU and US and changes on the horizon
• Debate scenarios where data extrapolation and government incentives might increase access to medicines in paediatric populations
• Optimise your approach to clinical success through global collaboration
• Evaluate new approaches to recruitment and retention for rare diseases

12:20 Networking Lunch

• PBPK to estimate dosing in first paediatric study
• Population PK to adapt dose recommendations and predict IV dosing
• Support of dose selection by PK-PD using adult data and data from a second compound

14:10 Optimising recruitment by ensuring family friendly information for paediatric

Jane Lamprill, Paediatric Research Consultant Specialist Medical Writer for Children and Member FP7 Ethics Panel, Paediatric Research Consultancy

14:50 Patient involvement in paediatric research and medicines development

• The voice of children in research: The European YPAG (Young Persons’ Advisory Group) network
• Collaborative research with the involvement of parents of children with rare disease
• Rare commons and Share4Rare platform

15:30 Afternoon Tea

16:00 European collaboration on paediatric research and regulation

Mark Turner, Chair, European Network of Paediatric Research at the European Medicines Agency and Senior Lecturer in Neonatal Medicine, University of Liverpool

• Patient recruitment across borders and the current state of European Networks
• How might Brexit impact the development and approval of new medicines will be regulated in the UK and are PIPs still likely to apply?
• What are the funding options for paediatric clinical research in the UK and the rest of Europe?
• Ensuring children have access to new medicines

16:40 Paediatric medicine regulation in the EU: What are the challenges and opportunities 10 years on?

• What effect have PIPs (paediatric investigation plans) had on the quality of the paediatric clinical trials and has this translated into greater efficiency in access to new approved medicines?
• What are future changes/limitations to paediatric research?
• Should extrapolation be the norm?
• How can these challenges be overcome now and in the future?

• Mechanism of action
• Development program
• Efficacy in paediatric ALL
• Changes in laboratory parameters
• Summary

11:40 Advances in paediatric formulation development: Baby steps

Trupti Dixit, Director, Strategy and Operations, Takeda

• What are the “Expectations” versus “Reality”?
• What approaches can be taken to bridge the gap in formulation development
• Conclusions

12:20 Networking Lunch

13:30 The UKs Early Access to Medicines Scheme (EAMS) – How can the scheme benefit paediatric patients?

Dominik Karres, Medical Assessor, Biologicals Unit, LD, MHRA

• The Promising Innovate Medicines (PIM) designation and the scientific opinion – what is the procedure and how does it work?
• How to weigh the risks and the benefits in cases of small numbers
• Real life examples

• Global paediatric collaboration and how paediatric drug development differs according to countries
• Paediatric research initiatives and networks: Exploring how these can improve drug development
• Developing a common scientific approach to enable effective patient access to approved medicines

14:50 Afternoon Tea

15:20 Early phase clinical trials in children: How paediatric pharmacology can help?

• Developing a deliverable protocol
• Adapting risks and benefits to needs of children and parents
• Delivering the study safely, and to time and target
• Capacity building within the specialty: developments in paediatric pharmacology training in the UK including the addition of early phase clinical trial experience and Faculty of Pharmaceutical medicine collaboration

16:00 Directions in therapeutic vaccination in children

David McIntosh, Honorary Clinical Senior Lecturer , Imperial College London

• How can successes in adult therapeutic vaccination be translated to children?
• What therapeutic areas in children may benefit from this approach?
• The immune systems of adults and children: similarities and differences
• What are the sorts of clinical trials that need to be performed in children?

16:40 Advanced therapy medical products (ATMPs) in Children

Robb Kahn, Drug Safety Consultant Clinical Development, Kite Pharma

• The status of development of cell and gene therapies in the EU
• The path to translation outside of the academic realm and into licensed, marketable medicines.
• Discussion of CAR T therapy for children with ALL as a model for ATMPs in paediatrics

Trupti Dixit

Workshops

Workshop

VENUE

Copthorne Tara Hotel

Scarsdale Place, Kensington, London, United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

SAVE TO

Copthorne Tara Hotel

Scarsdale Place
Kensington
London W8 5SR
United Kingdom

The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

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WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy,
which maintains that in order to be effective, learning should be organised and
structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional
competence’

CPD is a common requirement of individual membership with professional bodies and
Institutes. Increasingly, employers also expect their staff to undertake regular
CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do
not become obsolete, and allows for best practice and professional standards to
be upheld.

CPD can be undertaken through a variety of learning activities including instructor
led training courses, seminars and conferences, e:learning modules or structured
reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with
a collective membership of circa 4 million professionals, and they all expect their
members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked
to a licence to practice, for others it’s obligatory. By ensuring that their members
undertake CPD, the professional bodies seek to ensure that professional standards,
legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide
online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’
or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve
within a given time period. These schemes can also use different ‘currencies’ such
as points, merits, units or credits, where an individual must accumulate the number
required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of
learning.

‘Output’ based schemes are learner centred. They require individuals to set learning
goals that align to professional competencies, or personal development objectives.
These schemes also list different ways to achieve the learning goals e.g. training
courses, seminars or e:learning, which enables an individual to complete their CPD
through their preferred mode of learning.

As a formal provider of CPD certified activities, SMI Group can provide an indication
of the learning benefit gained and the typical completion. However, it is ultimately
the responsibility of the delegate to evaluate their learning, and record it correctly
in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces
and looking to the UK to benchmark educational standards. The undertaking of CPD
is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk